Job Description Summary
The QC Technician performs Quality control analysis on finished Product as well as in incoming materials according to cGMP r and SOPs, performs routine GxP Compliance/ Operational activities according to Novartis Quality Standards and makes analysis on batches and incoming materials according to cGMP rules and SOPs.
Job Description
In this role you will be required to work in rotating shifts, including night turns.
Major accountabilities:
- Perform the analysis of batches following specific training;
- Perform routine maintenance and cleaning, periodic microbiological verification of pharmaceutical areas quality control equipment and support external specialized personnel in carrying out extraordinary maintenance/qualification activities;
- Perform incoming and outgoing verification activities of raw materials and materials;
- Execute the calibration, verification, qualification and validation activities of the Quality Control processes and equipment
- Responsible for the oversight on manufacturing for QC sampling activities.
- Raw Material and Finished Product testing, Environmental Monitoring and Sterility QC testing, and reporting of the QC results. Escalation in case of non-conformances and deviations and manage these quality incidents as per AAA procedures.
- Support deviation investigations, OOS/OOT/OOE investigations, CAPA follow up and implementation, and Change Control management, including procedure and form revisions.
- Participation in assigned qualification/validation activities, as necessary.
- Prepares applicable documents, forms, and records such as analytical batch records and follows Good Documentation Practices.
- Support internal and external Audits and Inspections, as required.
Minimum Requirements:
- Education: Chemical or biological degree is desirable.
- Previous experience in radiopharmaceutical companies is desirable
- Fluent Italian, good knowledge of English.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Skills Desired
